The VALIDATE Chem 1 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.

Device Description

VALIDATE Chem 1 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

AI/ML Overview

The provided 510(k) summary describes the VALIDATE Chem 1 Calibration Verification Test Set, a device intended for in vitro diagnostic use to verify calibration, validate reportable ranges, and determine linearity for various analytes in chemistry systems. The study aims to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device, as implied by the substantial equivalence claim, is that its performance in verifying calibration and linearity for various analytes should be comparable to the legally marketed predicate devices. This is assessed through linear regression analysis, specifically by comparing correlation coefficients (r) and regression equations (Y = intercept + slope(X)). While explicit numerical thresholds for acceptance (e.g., minimum 'r' value, acceptable range for slope/intercept) are not directly stated in the provided text, the successful outcome of the 510(k) indicates that the FDA deemed the observed correlations and regression results to be acceptable for demonstrating substantial equivalence.

Given the context of calibration verification, ideal performance would be a correlation coefficient (r) close to 1, a slope close to 1, and an intercept close to 0, indicating a strong linear relationship and minimal bias compared to the reference.

Implicit Acceptance Criteria (based on the presented data and outcome):

High Correlation Coefficient (r): Values close to 1 (e.g., >0.99) for each analyte when compared to predicate devices.
Regression Equation indicating close agreement: Slopes close to 1 and intercepts close to 0 when comparing the candidate device's performance to the predicate a specific analyte.

Reported Device Performance (from Table 2 and continued Table 2):

Analyte	VALIDATE Chem 1 Calibration Verification Test Set (r)	VALIDATE Chem 1 Calibration Verification Test Set (Y=intercept+slope(X))	Predicate Device (r) (e.g., DOCUMENT Multi-Analyte CAL·VER)	Predicate Device Regression (Y=intercept+slope(X))
NA	0.99993	-2.455 + 1.017	0.99976 (DOCUMENT Direct ISE CAL·VER)	3.02 + 0.966
K	0.99964	-0.014 + 1.018	0.99983 (DOCUMENT Direct ISE CAL·VER)	-0.014 + 0.98
CL	0.99998	-0.175 + 1.002	0.99972 (DOCUMENT Direct ISE CAL·VER)	-3.751 + 1.017
CA	0.99992	-0.017 + 1.007	0.99995 (DOCUMENT Multi-Analyte CAL·VER)	-0.609 + 1.124
PO4	0.99999	-0.048 + 1.011	0.99985 (DOCUMENT Multi-Analyte CAL·VER)	-0.167 + 1.049
GLU	0.99998	-0.486 + 0.998	0.99994 (DOCUMENT Multi-Analyte CAL·VER)	2.529 + 1.02
BUN	0.99998	-0.729 + 1.016	0.99972 (DOCUMENT Multi-Analyte CAL·VER)	1.836 + 0.924
CRE	0.99999	-0.066 + 1.005	0.99997 (DOCUMENT Multi-Analyte CAL·VER)	-0.32 + 1.063
TRIG	0.99999	-3.002 + 1.004	0.99997 (DOCUMENT Iron, Magnesium, Triglyceride CAL·VER)	1.58 + 1.016
MG	0.99984	0.022 + 0.992	0.99913 (DOCUMENT Iron, Magnesium, Triglyceride CAL·VER)	0.138 + 1.009
LI	0.99978	0.074 + 0.982	0.99959 (DOCUMENT Direct ISE CAL·VER)	-0.052 + 0.986
LAC	0.99995	0.046 + 0.979	0.99990 (Roche Diagnostics Precitrol Ethyl Alcohol/Ammonia/Lactate Controls)	-0.049 + 1.00
NH3	0.99498	29.859 + 0.905	0.99945 (DOCUMENT Ammonia/Ethanol CAL·VER)	10.778 + 0.915
ETOH	0.99948	2.281 + 0.965	0.99992 (DOCUMENT Ammonia/Ethanol CAL·VER)	1.609 + 0.971

Interpretation: The reported correlation coefficients are all very high (ranging from 0.99498 to 0.99999), indicating a strong linear relationship between the new device and the predicate devices for all analyzed analytes. The regression equations generally show slopes close to '1' and intercepts relatively close to '0', further supporting the claim of substantial equivalence. The FDA concurred with this assessment, indicating that these results were acceptable.

2. Sample size used for the test set and the data provenance

Sample Size for the Test Set:
- The test set consists of the "VALIDATE Chem 1 Calibration Verification Test Set" and several predicate devices.
- The VALIDATE Chem 1 consists of 6 levels (including zero) for each of the 14 analytes.
- Each analyte was tested in triplicate.
- This means for each analyte, there were 6 levels * 3 replicates = 18 data points for the VALIDATE Chem 1.
- For the predicate devices, they mostly consisted of 5 levels (some 1 low and 1 high for the Roche control). Assuming they were also run in triplicate for comparison, this would contribute similar numbers of data points per analyte.
- The "test set" in this context refers to the collection of measurements taken using both the new device and the predicate devices for statistical comparison.
- It is mentioned that "pre-production lots" of the VALIDATE Chem 1 were used.
Data Provenance: The study was conducted by Maine Standards Company. There is no explicit mention of the country of origin of the data, but the submitter is based in Windham, ME, USA. The study appears to be prospective in nature, as it involved actively running pre-production lots of the new device and comparing them to existing predicate devices on a specified instrument (Roche Diagnostics Hitachi 911).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving human interpretation or subjective 'ground truth' establishment. The ground truth for calibration verification materials typically relies on the precisely defined concentrations of analytes within the reference materials themselves, which are then measured by the instrument. The 'ground truth' here is the expected response of the instrument to known concentrations, and the comparison is against predicate devices which also have established (or claimed) linearity and calibration verification properties.

4. Adjudication method for the test set

Not applicable. There was no human adjudication process involved in this study. The comparison was purely quantitative, using linear regression analysis between device measurements and predicate device measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a study involving human readers or AI assistance. It's a laboratory device performance study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense, a "standalone" performance was evaluated. The VALIDATE Chem 1 Calibration Verification Test Set itself is a standalone product (a set of solutions). Its performance was assessed independently by running it on an instrument (Roche Diagnostics Hitachi 911) and then statistically comparing its results to those obtained from predicate devices. There's no human 'in the loop' acting as an interpreter of the primary output of the calibration verification material, rather they are users of the material within a chemistry system.

7. The type of ground truth used

The "ground truth" for this study is essentially the expected or established performance/linearity of the predicate devices. The study aims to show that the new device performs similarly. The predicate devices themselves are accepted calibration verification materials, and their performance serves as the benchmark against which the new device is compared. The underlying "truth" for any calibration verification material lies in the precisely manufactured and quantified concentrations of the analytes within the solutions.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a "training set." It is a chemical reagent product used for calibration verification.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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510(k) SUMMARY

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

"The assigned 510(k) number is: KO12117

Submitter:	Maine Standards Company
Address:	765 Roosevelt Trail
	Windham, ME 04062
Telephone:	207-892-1300
Fax:	207-892-2266
Contact:	Christine Beach, Mgr. RA/QA

Summary prepared on: June 29, 2001

Proprietary Name:	VALIDATE Chem 1 Calibration Verification Test Set
Common Name:	Calibration Verification
Classification Name:	Calibrator, Multi-Analyte

Predicate Devices:

DOCUMENT Multi-Analyte CAL-VER, K870252, manufactured by 1. CASCO NERL Diagnostics.
1. DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics.
DOCUMENT Iron/Magnesium/Triglyceride CAL-VER, K893142, ని. manufactured by CASCO NERL Diagnostics.
DOCUMENT Ammonia/Ethanol CAL-VER, K962629, manufactured by বাঁ CASCO NERL Diagnostics.
Precitrol Ethyl Alcohol/Ammonia/Lactate Control, Roche Diagnostics. ട്.

Device description: VALIDATE Chem 1 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

Intended use: VALIDATE Chem 1 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.

Office location . 765 Roosevelt Trail . Windham, Maine 04062 Mailing address • P.O. Box 8360 • Portland, ME 04104-8360 Tel. 207.892.1300 ・ Fax 207.892.2266 ・ Toll Free 800.377.9684

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Comparison of VALIDATE Chem 1 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 1 Calibration Verification Test Set with those of the DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, DOCUMENT Iron, Magnesium, Triglyceride CAL•VER, DOCUMENT Ammonia/Ethanol CAL•VER, and Roche Diagnostics Precitrol Ethyl Alcohol/Ammonia/Lactate Control.

	VALIDATECHEM 1CalibrationVerification TestSet	DOCUMENTMulti-AnalyteCAL·VER	DOCUMENTDirect ISECAL·VER	DOCUMENTIron,Magnesium,TriglycerideCAL·VER
Catalog #	10001	M-100	M-101	M-103
Intended Use	For in vitrodiagnostic use inquantitativelyverifyingcalibration,validatingreportableranges, anddetermininglinearity inautomated, semi-automated andmanual chemistrysystems.	For in vitrodiagnostic use inthe quantitativedetermination oflinearity inmanual,automated andsemi-automatedchemistrysystems.	For in vitrodiagnostic use inthe quantitativedetermination oflinearity inmanual,automated andsemi-automatedchemistrysystems.	For in vitrodiagnostic use inthe quantitativedetermination oflinearity inmanual,automated andsemi-automatedchemistrysystems.
Analytes	NA, K, CL, CA,PO₄, GLU, BUN,CRE, TRIG, MG,LAC, NH₃ETOH, LI	GLU, BUN, NA,K, CL, CRE, CA,PO₄	NA, K, CL, LI	MGTRIG
Matrix	aqueous	aqueous	aqueous	aqueous
Number ofLevels	6 including Zero	5	5	5
Preparation	Liquid,ready to use	Liquid,ready to use	Liquid,ready to use	Liquid,ready to use
Packaging	5.0 mL each level	15.0 mL eachlevel	10.0 mL eachlevel	10.0 mL eachlevel
Stability	Until Expiration	Until Expiration	Until Expiration	Until Expiration
Storage	2-8°C	18-25°C	18-25°C	2-8°C

Comparison of Products TABLE 1.

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TABLE 1: continued

	VALIDATE CHEM 1CalibrationVerification Test Set	DOCUMENTAmmonia/EthanolCAL·VER	Roche DiagnosticsPrecitrol EthylAlcohol/Ammonia/Lactate ControlsLow and High
Catalog #	10001	M-100	1775812 / 1775782
Intended Use	For in vitro diagnosticuse in quantitativelyverifying calibration,validating reportableranges, and determininglinearity in automated,semi-automated andmanual chemistrysystems.	For in vitro diagnosticuse in the quantitativedetermination oflinearity in manual,automated and semi-automated chemistrysystems.	For use as anassayed controlmaterial to aid in theassessment of day-to-day performanceof automated, semi-automated ormanual chemistrysystems.
Analytes	NA, K, CL, CA, PO4,GLU, BUN, CRE, TRIG,MG, LAC, NH3ETOH, LI	NH3ETOH	LAC
Matrix	aqueous	aqueous	aqueous
Number ofLevels	6 including Zero	5	1 low and 1 high
Preparation	Liquid,ready to use	Liquid,ready to use	Liquid,ready to use
Packaging	5.0 mL each level	3.0 mL each level	4.0 mL each level
Stability	Until Expiration	Until Expiration	Until Expiration
Storage	2-8°C	2-8°C	2-8°C

The performance of VALIDATE Chem 1 Calibration Verification Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, DOCUMENT Iron, Magnesium, Triglyceride CAL•VER, DOCUMENT Ammonia/Ethanol CAL•VER, and Roche Diagnostics Precitrol Ethyl Alcohol/Ammonia/Lactate Control has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 1 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 1 Calibration Verification Test Set and the predicate devices are presented in Table 2.

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	VALIDATEChem 1CalibrationVerification Test Set		DOCUMENTMulti-AnalyteCAL·VER		DOCUMENTDirect ISECAL·VER		DOCUMENTIron, Magnesium,TriglycerideCAL·VER
Analyte	CorrelationCoefficient(r)	RegressionEquationY=intercept+ slope(X)	CorrelationCoefficient(r)	RegressionEquationY=intercept+ slope(X)	CorrelationCoefficient(r)	RegressionEquationY=intercept+ slope(X)	CorrelationCoefficient(r)	RegressionEquationY=intercer+ slope{X
NA	0.99993	-2.455 +1.017	N/A	N/A	0.99976	3.02 +.966	N/A	N/A
K	0.99964	-.014 +1.018	N/A	N/A	0.99983	-.014 +.98	N/A	N/A
CL	0.99998	-.175 +1.002	N/A	N/A	0.99972	-3.751 +1.017	N/A	N/A
CA	0.99992	-.017 +1.007	0.99995	-.609 +1.124	N/A	N/A	N/A	N/A
PO4	0.99999	-.048 +1.011	0.99985	-.167 +1.049	N/A	N/A	N/A	N/A
GLU	0.99998	-.486 +.998	0.99994	2.529 +1.02	N/A	N/A	N/A	N/A
BUN	0.99998	-.729 +1.016	0.99972	1.836 +.924	N/A	N/A	N/A	N/A
CRE	0.99999	-.066 +1.005	0.99997	-.32 +1.063	N/A	N/A	N/A	N/A
TRIG	0.99999	-3.002 +1.004	N/A	N/A	0.99997	1.58 +1.016	0.99997	1.58 +1.016
MG	0.99984	.022 +.992	N/A	N/A	0.99913	.138 +1.009	0.99913	.138 +1.009
LI	0.99978	.074 +.982	0.99959	-.052 +.986	N/A	N/A	N/A	N/A

Linear Regression Statistical Comparison of VALIDATE Chem 1 TABLE 2. Calibration Verification Test Set to the predicate devices.

TABLE 2: continued

VALIDATEChem 1Calibration Verification TestSet		DOCUMENTAmmonia/EthanolCAL·VER		Roche DiagnosticsPrecitrol EthylAlcohol/Ammonia/LactateControl Low and High
Analyte	CorrelationCoefficient(r)	RegressionEquationY=intercept +slope(X)	CorrelationCoefficient(r)	RegressionEquationY=intercept +slope(X)	CorrelationCoefficient(r)	RegressionEquationY=intercept +slope(X)
LAC	0.99995	.046 + .979	N/A	N/A	0.99990	-.049 + 1.00
NH3	0.99498	29.859 + .905	0.99945	10.778 + .915	N/A	N/A
ETOH	0.99948	2.281 + .965	0.99992	1.609 + .971	N/A	N/A

Summary:

Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 1 Calibration Verification Test Sei has been shown to be functionally equivalent for calibration and linearity assessment to DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER DOCUMENT Iron, Magnesium, Triglyceride CAL.VER, DOCUMENT Ammonia/Ethano CAL. • VER, and Roche Diagnostics Precitrol Ethyl Alcohol/ Ammonia/Lactate Control.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble a person.

AUG 2 0 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Christine V. Beach Manager, RA/QA Maine Standards Company, LLC 765 Roosevelt Trail Windham, ME 04062

510(k) Number: K012117 Re: Trade/Device Name: VALIDATE Chem 1 Calibration Verification Test Set Regulation Number: 862.1660 Regulatory Class: Class I, Reserved Product Code: JJY Dated: July 3, 2001 Received: July 6, 2001

Dear Ms. Beach:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, ( Sase contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on your respons and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: Holall ] | 7 | 2

Device Name: VALIDATE Chem 1 Calibration Verification Test Set

Indications for Use:

The VALIDATE Chem 1 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Division Sign-Off)
Division o. nical Laboratory Devices
510(k) Number KC12/17

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.